NCT04281290Active, not recruiting
Electrochemotherapy of Posterior Resection Surface for Lowering Disease Recurrence Rate in Pancreatic Cancer (PanECT Study)
Electrochemotherapy of Posterior Resection Surface for Lowering Disease Recurrence Rate in Pancreatic Cancer
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
The aim of the study is to evaluate toxicity and effectiveness of electrochemotherapy (ECT) with bleomycin in pancreatic cancer in clinical study phase I and II. After surgical resection of pancreatic cancer, the posterior resection surface will be treated with ECT with the intention to lower disease recurrence rate. The study will include 10patients in phase I clinical study and additional 10patients in phase II clinical study (or in the extension of the clinical study), which will fulfill inclusion criteria. Treatment effectiveness will be evaluated by US or CT imaging, to detect early local recurrence of the disease. Long term effectiveness of the treatment will be evaluated by frequent and precise patient follow-up. During follow-up clinical examination, laboratory tests, tumor markers (Ca 19-9 and CEA) and US/CT imaging will be performed. The secondary objectives of the trial are to quantify the impact of the treatment on the patient's quality of life, tolerance to the therapy and suitability for larger study to be conducted.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 14 Jan 2020
- Start date
- 13 Jul 2020
- Primary completion date
- 8 May 2023
- Lead sponsor
- University Medical Centre Ljubljana
- Diseases
- Pancreatic cancer
- NCT number
- NCT04281290
What you commit to
- Study type: Interventional
- Participants enrolled: 10
- From 13 Jul 2020 to the primary completion date, 8 May 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Cumulative dose of 250 mg/m2 bleomycin received.
Other illness
- Secondary primary tumor, except surgically treated noninvasive cancer of cervix, or surgically or irradiated basal cell carcinoma.
- Allergic reaction to bleomycin.
- Patients with epilepsy.
- Patients with arrhythmias.
- Patients with heart failure or pacemaker.
Lab values
- Life-threatening infection and/or heart failure and/or liver failure and/or renal failure (creatinine more than 150 µmol/L) other severe systemic pathologies.
Age
- Age less than 18 years.
Other
- Proven visceral, bone or diffuse metastases.
- Significant reduction in respiratory function.
- Pregnancy.
- Patient incapable of understanding the aim of the study or disagree with the entering into the clinical study.
Who the study is looking for
- Patients with resectable pancreatic cancer.
- Histologically confirmed and/or based on radiological imaging and laboratory tests confirmed pancreatic cancer by multidisciplinary team for pancreatic tumors.
- Age more than 18.
- Life expectancy more than 3 months.
- Performance status - Karnofsky ≥ 70 or WHO \< or 2.
- Treatment free interval 2-5 weeks, depending on the drugs used.
- Patient must be mentally capable of understanding the information given.
- Patient must give informed consent.
- Patient must be discussed at the multidisciplinary team for pancreatic tumors before entering the trial.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Centre Ljubljana, Ljubljana, Slovenia Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.